MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; DRYING CABINET

Model Number	DRYING CABINET
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the time of the reported event, a steris service technician was performing service activity on the amsco drying cabinet.The technician had unlatched and partially opened the upper door and went around the cabinet to the clean side to service the dryer.While the technician was on the clean side, the employee subject of the event opened the main door of the dryer causing the upper door panel to drop down and contact her head.The technician completed his service activity, tested the function and operation of the device and confirmed it to be operating to specification.The amsco drying cabinet was returned to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that when an employee was opening the door to their amsco drying cabinet, the upper door panel dropped down and contacted the employee's head.The employee sought and received medical treatment.

• Brand Name: AMSCO
• Common Device Name: DRYING CABINET
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23863110
• Report Number: 9680353-2025-00054
• Device Sequence Number: 9350209
• Product Code: PUP
• UDI-Device Identifier: 00724995216290
• UDI-Public: (01)00724995216290(11)230627
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRYING CABINET
• Device Catalogue Number: DCR100101XL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown